Hazelwood

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are investigating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid (sUA) levels in adults with hyperuricemia related to gout. This phase 3, randomized, double-blind trial focuses on adults aged 18 to 75 who have had gout for at least one year and experienced multiple gout flares in the past year. The study aims to assess the percentage of participants achieving an sUA level below 6.0 mg/dL at 24 weeks. Participants receive either dotinurad or allopurinol as oral over-encapsulated tablets. Allopurinol doses range from 200 mg/day for those with moderate kidney impairment to 600 mg/day, with participants maintaining a stable dose for at least three months before starting the study. The trial includes a 24-week treatment period where the effects of these medications on uric acid levels are monitored and compared. During the study, participants undergo regular assessments including serum uric acid measurements at screening and throughout the 24 weeks. Female participants of childbearing potential have pregnancy tests and must agree to contraception requirements. Researchers monitor safety, treatment adherence, and gout flare history to evaluate the treatments' efficacy and tolerability over the study period.

Researchers are investigating the effects of QCZ484 in patients with mild to moderate hypertension. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and pharmacodynamics of QCZ484 compared to a placebo, using various doses administered subcutaneously every 6 months. Participants will receive multiple doses of QCZ484 or a saline placebo through subcutaneous injections over a 12-month treatment period. The study will carefully test different dose levels to identify the optimal dosing strategy for patients with hypertension. Throughout the study, participants will be monitored for changes in their mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring at baseline and after 3 months. Safety and tolerability will also be assessed, including regular laboratory tests and clinical evaluations. The trial includes detailed assessments to ensure participants understand and comply with study procedures during the entire duration.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 2 study to assess the efficacy and safety of iloperidone for treating adults aged 18 to 65 with uncontrolled hypertension. The study focuses on participants whose systolic blood pressure remains 130 mmHg or higher despite at least 8 weeks of treatment with one or more antihypertensive therapies. This trial aims to understand how iloperidone affects blood pressure control in this population. Participants will be randomly assigned to receive either iloperidone or a placebo. The treatments are administered as drugs, with participants and researchers blinded to the assignments. The study measures changes in systolic blood pressure from baseline to the fourth week of treatment to evaluate the effects of iloperidone compared to placebo. During the study, participants will undergo blood pressure monitoring and safety assessments. The primary outcome is the change in sitting systolic blood pressure after 4 weeks of treatment. The study excludes individuals with severe hypertension, unstable heart disease, or kidney problems to ensure participant safety. The trial duration includes at least 4 weeks of treatment, with ongoing monitoring for efficacy and safety.

Researchers are evaluating the effectiveness, safety, and tolerability of Suzetrigine in adults with pain caused by diabetic peripheral neuropathy (DPN). This phase 3 study focuses on participants who have had diabetes type 1 or type 2 with bilateral lower limb pain for at least one year and aims to compare Suzetrigine's effects against a placebo. Participants will receive either Suzetrigine tablets or a placebo that looks like Suzetrigine, taken orally. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives which treatment. The main goal is to measure the change in weekly average daily pain intensity using the Numeric Pain Rating Scale (NPRS) over 12 weeks. During the study, participants will track their daily pain levels to assess treatment effects. Researchers will monitor safety and tolerability throughout the 12-week period, focusing on changes in pain intensity compared to the baseline. Participants must weigh at least 45 kilograms and have a body mass index between 18 and 40 kg/m². The study allows adults aged 18 to 80 years with controlled diabetes and specific pain levels to join.

Researchers are evaluating the effectiveness, safety, and tolerability of Suzetrigine tablets in adults with pain caused by diabetic peripheral neuropathy (DPN). This phase 3 study compares Suzetrigine to a placebo and to Pregabalin capsules, both taken orally. Participants have type 1 or type 2 diabetes with nerve pain in their lower legs and meet specific pain severity levels. Participants receive either Suzetrigine tablets or a matching placebo, and some receive Pregabalin capsules or a matching placebo. The study is randomized and double-blind, meaning neither participants nor researchers know who receives which treatment during the trial. Treatments are taken orally over a 12-week period to assess their impact on pain. During the study, participants track their daily pain intensity using a numeric pain rating scale. Researchers measure the change in average weekly pain score from baseline to week 12. Safety, tolerability, and any side effects are monitored throughout. Participants must meet weight and body mass index criteria and have stable pain levels before starting. The total participation time includes a baseline period and 12 weeks of treatment.

Researchers are evaluating the effectiveness, safety, and tolerability of an oral drug called VX-993 in adults experiencing pain related to Diabetic Peripheral Neuropathy (DPN), a painful condition caused by nerve damage due to diabetes. This Phase 2 study compares VX-993 to pregabalin, a drug commonly used to treat nerve pain, as well as to placebo treatments matched to each drug. Participants will receive tablets of VX-993 or capsules of pregabalin, or matching placebos, in a dose-ranging, randomized, double-blind, parallel design. The study aims to assess responses to these treatments over a set period, focusing on reducing pain intensity associated with DPN. During the 12-week treatment period, participants' daily pain intensity will be regularly measured using a numeric pain rating scale to track changes from the start of the study. Researchers will monitor safety, tolerability, and treatment effects throughout the study. The trial includes adults aged 18 to 80 years with diabetes and chronic nerve pain in their lower limbs due to DPN.

Menstrual migraine is a type of moderate to severe headache occurring around the time of menstruation, often accompanied by symptoms like nausea, vomiting, and sensitivity to light and sound. This trial evaluates the safety and effectiveness of ubrogepant, a drug being studied as a short-term preventive treatment for menstrual migraine. Adult women who experience migraine attacks in at least two out of three menstrual cycles are invited to participate in this Phase 3 study. Participants will be randomly assigned to receive either oral ubrogepant tablets or a placebo once daily for 7 consecutive days, starting 3 days before the expected start of their period, across three menstrual cycles during a 16-week double-blind treatment phase. Those who qualify may continue taking ubrogepant daily for 7 days per cycle during a 52-week open-label extension. The study involves about 496 women at around 100 sites across the United States and Puerto Rico. Throughout the study, participants will record daily information in electronic diaries and attend regular clinic visits. Researchers will monitor treatment effects through medical assessments, blood tests, questionnaires, and side effect checks. The main outcomes measured include changes in the number of migraine days during perimenstrual periods over 16 weeks and the number of participants experiencing adverse events up to approximately 68 weeks.